Alcohol and Gender Effects on Stress Circuit Function

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00226694
First received: September 23, 2005
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to look at the stress hormone response to medication-induced stress and a placebo (an inactive compound) in non-drinking, recovering male and female alcoholics, with a specific emphasis on the differences between men and women in the two recovering alcoholic groups.


Condition Intervention
Alcoholism
Stress
Alcohol Dependence
Drug: Citalopram
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Alcohol and Gender Effects on Stress Circuit Function

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • stress [ Time Frame: month ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: September 2003
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citalopram Group
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Drug: Citalopram
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Other Name: Celexa
Placebo Comparator: Placebo Group
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Other: Placebo
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Other Name: Sugar Pill

Detailed Description:

Women and men differ in the ways stress affects the development and maintenance of alcoholism. However, no published studies in alcohol dependent patients have examined sex differences in stress responsiveness that most likely mediate these effects and influence the clinical course and treatment of the disorder.

The long-range goal of this research program is to define aspects of the neural, genetic and environmental mechanisms differentially regulating the stress response in alcohol dependent women and men. The proposed study extends prior work revealing sex-dependent alterations in basal and serotonin-induced stress hormone concentrations in abstinent alcoholics. Our central hypothesis is that sex differences in serotonin function or HPA sensitivity conspire with genetically influenced alterations in serotonin signaling to produce maladaptive stress responses in some alcoholic women. These altered stress responses may serve as the target of novel, sex-specific pharmacotherapies.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to provide written consent.
  • Are actively engaged in a recovery program for alcoholism;
  • Have a current (within the past 12 months) diagnosis of DSM-IV alcohol dependence in early- (modified to a minimum of 4 months) full remission; and
  • Are residing in a controlled sober living environment; and
  • Agree to provide at least one collateral informant who knows the subject well and can attest to their sobriety (recovering alcoholics only).

Exclusion Criteria:

  • Have evidence of any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, thyroid or other endocrine disease;
  • Are taking oral contraceptives or other hormonal replacements (e.g., estrogen or progesterone);
  • Are pregnant, or planning to become pregnant during the next 9 months;
  • Have taken other psychotropic drugs (including SSRIs, MAO inhibitors and other antidepressants, antipsychotics, mood stabilizers, non-benzodiazepine anxiolytics or hypnotics) within 6 weeks of the first laboratory session;
  • Have taken any investigational drug within 90 days of the first laboratory session; or
  • Are making efforts to quit smoking or have taken any pharmacotherapies for smoking cessation (i.e., bupropion, nicotine-replacement patches or gum; clonidine, buspirone) within 90 days of the first laboratory session.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226694

Locations
United States, Ohio
The Department of Veterans Affairs / Veterans Healthcare System of Ohio
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Robert M. Anthenelli, MD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00226694     History of Changes
Other Study ID Numbers: NIAAAANH013307, R01AA013307, NIH R01 AA013307-01
Study First Received: September 23, 2005
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Cincinnati:
Alcoholism
Stress
Gender Differences
Addiction
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Citalopram
Corticotropin-Releasing Hormone
Dexamethasone
Dexetimide
Anti-Dyskinesia Agents
Anti-Inflammatory Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics

ClinicalTrials.gov processed this record on October 20, 2014